(176 days)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-209 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16.5 km and Max. speed forward is 6km/h. The braking time is about 2s, and the braking distance is less than or equal to 1.76m.
The provided text describes a 510(k) submission for a Powered Wheelchair (NXN20-209). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a comparative study with a "human-in-the-loop" component as is common for AI/ML-driven diagnostics. The information provided is primarily related to engineering performance and safety standards for the physical device itself.
Therefore, the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, as phrased for AI/ML device performance (e.g., sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment), is not applicable in the context of this traditional medical device submission.
The document states: "No clinical study implemented for the electric wheelchair." This confirms that the typical clinical performance studies asked for in your prompt were not conducted or required for this device's clearance.
Instead of AI/ML-specific performance criteria, the acceptance criteria for this powered wheelchair are based on adherence to recognized international standards for wheelchairs and a comparison of its physical and performance characteristics to a predicate device.
Here's a breakdown of what the document does provide in relation to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
The document includes two comparison tables (Table 1: General Comparison and Table 2: Performance Comparison) that demonstrate the similarity and conformance of the proposed device to a predicate device and relevant standards. While not "acceptance criteria" in the sense of a specific numerical threshold for a diagnostic outcome, these aspects represent the performance benchmarks the device successfully met.
Table 1 & 2 (summarized and adapted to your request format):
| Acceptance Criteria Category | Specific Metric/Standard | Reported Device Performance (NXN20-209) | Predicate Device (A08) Performance | Remark/Acceptance Demonstrated By |
|---|---|---|---|---|
| General Characteristics | Product Code | ITI | ITI | Same (Substantially Equivalent) |
| Regulation No. (21 CFR) | 890.3860 | 890.3860 | Same (Substantially Equivalent) | |
| Classification | Class II | Class II | Same (Substantially Equivalent) | |
| Intended Use | Motor driven, indoor/outdoor transportation for disabled/elderly limited to seated position | Motor driven, indoor/outdoor trans. for disabled/elderly limited to seated position | Same (Substantially Equivalent) | |
| Driving system | Direct drive on rear wheels | Direct drive on rear wheels | Same (Substantially Equivalent) | |
| Movement control method | By Joystick control | By Joystick control | Same (Substantially Equivalent) | |
| Number of wheels | 4 | 4 | Same (Substantially Equivalent) | |
| Brake system | Automatic electromagnetic brake system | Electromagnetic brake system | Same (Substantially Equivalent) | |
| Speed control method | Joystick control method | Joystick control method | Same (Substantially Equivalent) | |
| Performance Metrics | ISO 7176-1:2014 Static Stability | Forward: 18.9°, Rearward: 18.2°, Sideways: 20.7° | Not publicly available | Both devices evaluated according to same standard; differences in static stability will not impact safety and effectiveness. |
| ISO 7176-4:2008 Cruising Range | 16.5 km | 20 km | Complies with ISO 7176-4:2008; differences do not affect safety and effectiveness. | |
| ISO 7176-3:2012 Minimum Braking Distance | ≤ 1.76m | 1m | Similar; compliant with standard. | |
| ISO 7176-6:2018 Max Speed Forwards | 1.66 m/s (6 km/h) | 1.94m/s (7 km/h) | Both devices evaluated according to same standard; differences will not impact safety and effectiveness. | |
| ISO 7176-6:2018 Max Speed Backward | 0.8 m/s (2.88 km/h) | Not publicly available | Both devices evaluated according to same standard; differences will not impact safety and effectiveness. | |
| Max. loading (weight capacity) | 242.5 lbs (110 kg) | 220 lbs (100 kg) | Device supports more loading weight without raising new safety/effectiveness concerns. | |
| Min. Turning Radium | 870mm | 800mm | Similar performance. | |
| Obstacle climbing | 25 mm | 40 mm | Smaller height in obstacle climbing will not impact safety and effectiveness. | |
| Software Verification and Validation Testing | Compliant with FDA Guidance | Included | Compliance with FDA guidance for software functions documented. | |
| Safety & Materials | Biocompatibility of materials contacting user | Compliant with FDA Guidance, ISO 10993-1 | Compliant with ISO 10993-1, FDA Guidance (tests included) | Biocompatibility evaluation carried out per ISO 10993-1; no new safety and effectiveness concerns due to differences. |
| Compliance with EMC standards (IEC 60601-1-2:2020, ISO 7176-21:2009) | Performed (Implied by inclusion in Non-Clinical Testing Summary) | Performed (Implied by inclusion in Non-Clinical Testing Summary) | Test results demonstrated compliance. | |
| Compliance with other ISO 7176 series for safety, fatigue, dimensions etc. | Performed and Compliant | Performed (Implied by predicate clearance) | Test results demonstrated compliance with numerous ISO standards for wheelchairs. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human subjects "test set" was used for performance evaluation in the context of an AI/ML algorithm. The testing was non-clinical (bench and engineering tests) based on international standards for mechanical and electrical safety and performance of wheelchairs. The document does not specify a "sample size" for these non-clinical tests in the way one would for a clinical study. Data provenance is implied by the testing standards and the manufacturer's location (China), but not detailed as typical for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device. Performance is determined through objective, standardized engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Not a clinical study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic or image analysis device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical powered wheelchair, not an AI algorithm. Software verification and validation (standalone) was done for the device's control software, ensuring it functions correctly, but this is distinct from AI/ML performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Objective Standards. The "ground truth" for this device's performance is compliance with established international engineering and safety standards (e.g., ISO 7176 series, IEC 60601-1-2) which define objective, measurable criteria for stability, speed, braking, etc.
8. The sample size for the training set:
- Not Applicable. No AI/ML training set is mentioned or relevant for this device.
9. How the ground truth for the training set was established:
- Not Applicable. No AI/ML training set is mentioned or relevant for this device.
In summary: The provided document is for a traditional powered medical device, not an AI/ML-driven diagnostic or imaging device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to documented compliance with relevant recognized industry standards (primarily ISO and IEC) through non-clinical testing, and demonstrated substantial equivalence to a predicate device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
November 22, 2024
Zhejiang Nysin Medical Co., Ltd. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 China
Re: K241529
Trade/Device Name: Powered Wheelchair (NXN20-209) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 21, 2024 Received: October 21, 2024
Dear Boyle Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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ion, or data verification, provided by the FDA.
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2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Powered Wheelchair (NXN20-209)
Indications for Use (Describe)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K241529 - 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Zhejiang Nysin Medical Co., Ltd. Address: Building 13, No. 305 Jiulong North Road, Dongcheng District, Yongkang, Jinhua City, Zhejiang Province, China Tel: +86-579-87153722/ +86-18969388822 Contact: Zhang Xiaoying
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
Date of Preparation: Mar.28, 2024
2.0 Device information
Trade name: Powered Wheelchair Common name: Powered Wheelchair Classification name: Powered Wheelchair Model(s): NXN20-209
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Kunshan Aoshida Electric Technology Co., Ltd. Trade/Device: A08 Power Wheelchair 510(k) number: K163204
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5.0 Indication for Use Statement
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
6.0 Device description
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The NXN20-209 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire.
The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.
Max. loading can not be over than 110Kgs.
Max. distance of travel on the fully charged battery is 16.5 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.76m.
7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed,
acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths
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ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions for software.
The Software Validation is in compliance with FDA Guidance.
8.0_Summary of Clinical Testing
No clinical study implemented for the electric wheelchair.
9.0 Technological Characteristic Comparison Table
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| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Powered Wheelchair | A08 Power Wheelchair | - |
| 510(k) No. | K241529 | K163204 | - |
| Models | NXN20-209 | A08 | - |
| Intended Use | The device is a motor driven,indoor and outdoortransportation vehicle with theintended use to providemobility to a disabled orelderly person limited to aseated position. | It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use toprovide mobility to a disabledor elderly person limited to aseated position. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| PatientPopulation | This product is suitable fordisabled people with mobilitydifficulties and elderly people. | This product is suitable fordisabled people with mobilitydifficulties and elderly people. | Same |
| Product structure | Consist of two foldablearmrests, a backrest, a seatcushion, a safety belt, afoldable frame, two reardriving wheels with hubmotor/electromagnetic brakeassemblies, two pivotingcasters, two Li-ion batteries,an off-board battery charger, acontrol panel, and an electricmotor controller. | Consists primarily of afoldable welded-aluminumframes, two sealed transaxlemotors drive system,electromagnetic brakingsystem, electric motorcontroller and two Li-ionbatteries with an off-boardbattery charger. | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Movement controlmethod | By Joystick control | By Joystick control | Same |
| Number ofwheels | 4 | 4 | Same |
| Brake system | Automatic electromagneticbrake system | Electromagneticbrake system | Same |
| Main framematerial | Carbon fiber | Welded-aluminum | DifferentThe differences in themain frame material willot impact the safety andeffectiveness of thesubstantial equivalence. |
| Motor | Brushless motor,DC24V* 200W*2pcs | Brushless motor,24 VDC *250W * 2 pcs | Minor differences in thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| Battery | DC 24V 12Ah Lithium-ion, 2pcs | ||
| Battery charger | Off-board chargerInput: 100-240 VACOutput: DC 24V, 3A |
Table1-General Comparison
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Table2 Performance Comparison
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Model | NXN20-209 | A08 | -- |
| Overall length | 930mm | 890 mm | Minor differences in thedimensions will not impactthe safety and effectivenessof the substantialequivalence. |
| Overall width | 585mm | 603 mm | |
| Stowagelength | 740mm | 324 mm | |
| Stowage width | 265mm | 603 mm | |
| Stowageheight | 720mm | 670 mm | |
| Weight, w/Battery | 30.3 lbs. /13.75 kg | 61.7 lbs. /28 kg | The difference will not raiseany new safety andeffectiveness concerns. |
| Frontwheel(inch) | 7(PU solid tire) | 8(PU solid tire) | Smaller sizes of font wheels |
| Rear tire (inch) | 12(PU solid tire) | 10(PU solid tire) | Larger sizes of rear wheelsbring steadier pivotingfunction than predicatedevice. |
| CruisingRange(km) | 16.5 | 20 | The subject device complieswith ISO 7176-4: 2008Wheelchairs - Part 4: Energyconsumption of electricwheelchairs and scooters fordetermination of theoreticaldistance range, thesedifferences do not affectsafety and effectiveness. |
| Obstacleclimbing(mm) | 25 | 40 | The smaller height in theobstacle climbing will not |
| impact the safety andeffectiveness of the subjectdevice. | |||
| Static stabilityforward | 18.9° | Not publicly available | Both of the devices areevaluated according tostandard ISO 7176-1:2014,so the different static stabilitywill not impact the safetyand effectiveness |
| Static stabilityrearward | 18.2° | ||
| Static stabilitysideways | 20.7° | ||
| Max. loading(kg) | 242.5lbs(110kg) | 220 lbs (100 kg) | More loading weight meansmore convenient for thetransportation |
| Min. Turningradium | 870mm | 800mm | Same |
| Minimumbrakingdistance | $≤$ 1.76m | 1m | Similar |
| Max SpeedForwards | 1.66 m/s (6 km/h) | 1.94m/s (7 km/h) | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness |
| Max. SpeedBackward | 0.8 m/s (2.88 km/h) | Not publicly available | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness |
| Controller | Yanteon Mechanical &Electronic Technology(Shanghai) Co. Ltd.Joystick Y2450MController Y2430M | Yisheng Electric Co. Ltd ,WS-1, 40A | DifferentAlthough different controlleris used, both the controlsystem, including the joystickcontroller, theelectromagnetic brakes andthe user interface are similar.The joystick controls thedirections and speed ofmovement, and when thejoystick is released, thepowered wheelchair will slowdown to stop and the brakeswill automatically re-engage.The controller also providesthe battery status displaying |
| displaying. Both of the controlsystems are evaluatedaccording to standard ISO7176-14:2008 and softwarevalidation requirement andthere are no new safety andeffectiveness concerns dueto the difference. | |||
| Speed controlmethod | Joystick control method | Joystick control method | Same |
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Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materialscontacting user | Armrest: PU;Backrest/Seat/Seat belt:Sandwich mesh fabric(polyester)Safety Belt: NylonController Housing: ABSJoystick/button: SiliconeFootplates: ABS | Armrest: PU;Backrest/seat cushion: PU foamcovered by nylon fabric cloth | Biocompatibility evaluationhas been carried out perISO 10993-1. There are nonew safety andeffectiveness concerns dueto the difference. |
| Biocompatibilityof materialscontacting user | Comply with FDA Guidance | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Same |
Summary of substantial equivalence discussion:
The technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device under K163204.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).